Colazingari 2013

Methods	Randomised controlled trial
Participants	Women with PCOS attending an IVF clinic (n = 100) Inclusion criteria: BMI <28 and FSH <10 IU/L with a diagnosis of PCOS according to Rotterdam 2003 and a normal uterine cavity Exclusion criteria: advanced stage (III or IV) endometriosis and those classified as poor responders or as suffering from premature ovarian failure
Interventions	1. Myo‐inositol 550 mg and DCI 13.8 mg: 1 tablet of each twice a day (INOFOLIC combi, soft gel, Lo.Li. Pharma Roma, Italy; patented) (n = 47) 2. D‐chiro‐inositol 500 mg; 1 tablet twice a day (Interquim, s.a., Barcelona, Spain) (n = 53) Treatment was given for 12 weeks before rFSH administration and throughout pregnancy
Outcomes	Primary outcomes: number of morphologically mature oocytes, total IU of rFSH administered and the number of grade 1 embryos Secondary outcomes: E2 levels before hCG injection, the number of degenerated oocytes, maturation rate, fertilisation rate and the number of embryos transferred
Notes	The trial was registered on clinicaltrials.org (NCT1338844) Conducted in Italy No reproductive outcomes given in the data but pregnancy referred to in the text; emailed author regarding pregnancy outcomes 14th September 2016. Author replied on the 27th September 2016, saying that there are no pregnancy data available but that the trial was double‐blinded.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Patients were randomly assigned to a block of ten by a computer‐generated program"
Allocation concealment (selection bias)	Low risk	"The key to the coding of the treatments was kept by the Lo.Li. Pharma. Both the participants and the research team were blinded. The randomization code was not broken until the completion of the study"
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	"One of the patients who was enrolled and assigned to the MI‐DCI treated group decided to quit the IVF procedure due to personal reasons"
Selective reporting (reporting bias)	Low risk	All outcomes reported
Other bias	Low risk	No other bias found